Webinar Q&A follow up: Antibodies to watch in 2026

Thank you to everyone who attended our webinar ‘Antibodies to watch in 2026‘ in association with the journal, mAbs. Below are responses from speakers Janice Reichert and Silvia Crescioli to the questions posed by our audience during the live event. We hope this is a useful resource and thank those who submitted these thoughtful questions.

What do you think about the potential of oligoclonal or even recombinant polyclonal antibodies, for example against pathogens?

The concept has been explored in the past. For example, Symphogen developed a mixture of 25 recombinant antibodies, rozrolimupab, for treatment of idiopathic thrombocytopenic purpura. There are numerous examples of mixtures comprising two to six recombinant antibodies that have been evaluated in clinical trials. Most of these are/were targeted at an infectious agent or a toxin produced by an infectious agent.

Are you aware of any examples of platforms based on DNA-encoding antibodies in clinical testing?

INOVIO’s DMAb platform has been used to create several DNA-encoded antibodies, AZD5396 and AZD8076 (COVID-19 DMAbs) and INO-A002 (Zika virus), evaluated in clinical studies. A Phase 1 clinical trial (ClinicalTrials.gov: NCT05293249) evaluated safety, pharmacokinetics and sustained expression of AZD5396 and AZD8076 in healthy adults. INO-A002 / dMAb-ZK190 (Zika virus) was one of the first DNA-encoded mAb therapeutic candidates taken into a Phase 1 study (NCT03831503). In both cases, the clinical trials included healthy adults.

In addition to the DNA approach, Moderna, Inc. previously evaluated an mRNA-encoded monoclonal antibody (mRNA-1944) targeting chikungunya virus in a Phase 1 study of healthy adults (NCT03829384).

Most therapeutic mAbs still seem to originate from animals. What potential do you see in phage-display-derived antibodies?

While we have not attempted to comprehensively determine the methods used to create the molecules in the clinical pipeline (well over 1500 in number), we have identified numerous phage-display-derived antibodies. Although they comprise a relatively small percentage of the pipeline, at least 15 of the approved antibodies are phage-display-derived, as are two in regulatory review. Phage display is thus a viable method for the discovery of antibody therapeutics that can be successfully developed and approved for marketing.

What do you think about the current target space in general? Will targeting the intracellular pathways by antibodies increase?

Overall, we have not yet seen a clear expansion of antibody target space toward intracellular pathways, and most therapeutic antibodies still focus on extracellular or cell-surface targets. However, there are examples in the clinic and at the preclinical stage that indirectly address intracellular proteins, mainly through TCR–antibody fusion formats or TCR-mimetic antibodies that recognize peptide–HLA complexes on the cell surface. While promising, these approaches are still emerging and have not yet been widely adopted. Whether this will significantly increase remains to be seen, but advances in AI-driven epitope discovery and peptide–HLA prediction could help enable broader and more systematic targeting of intracellular proteins in the future.

Are there any trends toward the development of alternative delivery routes to intravenous injections?

Subcutaneous administration is generally perceived to be a more patient-friendly route of administration, although formulation is typically more difficult because a concentrated dose is required. Of the 19 antibodies first approved in 2025, seven products are administered subcutaneously and two products are administered intramuscularly, with the remainder approved as intravenously administered products.

Why do you think there has been a decrease in antibodies in the pipeline in the US and Europe? Have new tariffs and funding issues at the NIH and FDA had an effect?

The global commercial clinical pipeline has increased substantially in the past ~ 5 years due to the increase in antibody therapeutics R&D in China. There thus has not necessarily been a notable decrease in US- or Europe-originated antibodies, but they now represent a smaller percentage of the pipeline due to the increase in China-originated molecules. The new tariffs and funding issues occurred too recently to have substantially influenced the current clinical pipeline.

With US and European companies in-licensing Chinese compounds, how do you see the FDA and EMA accepting the Chinese clinical package?

The nature of the clinical package will depend on the stage of the molecule when in-licensed. A US/Europe-based licensee would likely conduct their own clinical studies for molecules in-licensed when they are at the preclinical or early clinical stages. If the license is for a molecule evaluated in late-stage studies performed only at sites in China, then potentially one or more bridging studies might be needed before a clinical package could be presented to FDA or EMA. The specific requirements would need to be discussed with the relevant regulatory agency or agencies.

Why does China have a shorter development phase?

There are likely multiple reasons that depend on the particular company, molecule and indication. However, it is possible that participant enrollment is faster due to the larger population and related greater medical need. In addition, the clinical phases have recently become compressed in an increasing number of cases. For example, upon completion of a Phase 1/2 study, a molecule might transition directly into a Phase 2/3 or Phase 3 study, rather than following the traditional path of evaluation in Phase 1, followed by Phase 2 and then Phase 3. In extreme cases, molecules may transition from Phase 1 directly to Phase 3 as part of the same study (i.e., single Phase 1/3 study). This compression of the studies shortens the clinical development phase. The approach is used by some Chinese companies, but it has also been used by companies based elsewhere.

Do you think Chinese approval rates are greater than in the US and Europe due to reduced safety standards?

No, we have not observed evidence of that.

To access the full on-demand webinar, click here.

Disclaimer
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of BioTechniques or Taylor & Francis Group.

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